Status:
COMPLETED
Internet-guided Cognitive Behavioral Therapy for Insomnia in Military Service Members With History of TBI
Lead Sponsor:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborating Sponsors:
Uniformed Services University of the Health Sciences
Center for Neuroscience and Regenerative Medicine (CNRM)
Conditions:
Insomnia Chronic
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This study aims to validate an established internet-guided cognitive behavioral therapy for insomnia (CBT-I) as an alternative program to traditional in-person therapy that may increase treatment avai...
Detailed Description
Traumatic brain injury (TBI) represents a major health problem in United States military service members. Mild traumatic brain injury, also called "concussion", accounts for approximately 90% of the o...
Eligibility Criteria
Inclusion
- Age 18-64
- Service member or veteran
- Ability to provide electronic informed consent and follow study-related instructions
- Presence of clinical insomnia for a period of at least 1 month prior to consent as confirmed by self-reported Insomnia Severity Index (ISI) score ≥15 and Pittsburgh Sleep Quality Index ≥5
- History of mild traumatic brain injury ≥6 months prior to consent, including blast-related, as confirmed by a telephone administered traumatic brain injury screener
- Reliable access to a telephone and the Internet via their computer or smartphone
- Stable regimen of medications for sleep or potentially affecting sleep over prior 1 month as confirmed by clinical history review
Exclusion
- Current or previous cognitive behavioral therapy for insomnia (CBT-I) or electronic CBT- I intervention; participants may still receive other approved therapies provided via standard of care
- Life expectancy of \<6 months
- Rapidly progressive illnesses (i.e., late-stage cancer, neurodegenerative conditions, major organ failure, etc.)
- Self-reported history of moderate to severe substance use disorders with the exception of nicotine
- Active bipolar disorder or psychosis that could be worsened by mild sleep restriction as part of electronic CBT-I
- Routine irregular work schedules or sleep patterns defined as shift work greater than 1 day per week
- Any other considerations that in the view of the principal investigator may adversely affect patient safety, participation, or scientific validity of the data being collected
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04377009
Start Date
July 7 2020
End Date
April 30 2023
Last Update
August 21 2023
Active Locations (1)
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1
Uniformed Services University
Bethesda, Maryland, United States, 20817